Long-Term Safety Study of Bicifadine for the Treatment of Chronic Low Back Pain
Completed
DOV Pharmaceutical, Inc.
Phase 3
The primary objective of the study is to evaluate the safety and efficacy of bicifadine 400
mg BID for up to one year in patients with moderate to severe chronic low back pain.
The secondary objectives are to compare the long-term safety of bicifadine to standard of
care therapy, to evaluate the safety of bicifadine following discontinuation of dosing, and
to evaluate the safety and efficacy of lower doses of bicifadine in patients who do not
tolerate bicifadine 400 mg BID.
Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain
Completed
DOV Pharmaceutical, Inc.
Phase 3
The primary objectives of this placebo-controlled clinical trial are to evaluate the
analgesic efficacy and safety of bicifadine at three oral dose levels compared with placebo
in patients with moderate to severe chronic low back pain.
The secondary objectives are to investigate the dose-response relationship of three dose
levels of bicifadine, to evaluate the clinical meaningfulness of bicifadine efficacy, to
evaluate the effect of bicifadine on function and general quality of life, to describe the
population pharmacokinetics of bicifadine in patients with chronic low back pain, and to
evaluate safety following discontinuation of bicifadine treatment.
Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain
Completed
DOV Pharmaceutical, Inc.
Phase 3
- The primary objectives of this placebo-controlled clinical trial are to evaluate the
analgesic efficacy and safety of bicifadine 200 mg BID compared with placebo in patients
with moderate to severe chronic low back pain.
- The secondary objectives are to evaluate the effect of bicifadine on function and
general quality of life, to evaluate safety following discontinuation of bicifadine
treatment and to investigate the population pharmacokinetics of bicifadine.
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